FDA.reportPublic FDA data

Prozac

Product NDC
0777-3104
11-digit product format
007773104
Labeler code
0777
Product ID
0777-3104_e49a90e3-e7da-4377-8736-ebe9f53c3097
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Dista Products Company
Application
NDA018936
Marketing category
NDA
Marketing start
1993-01-13
Marketing end
2026-12-06
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prozac

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui104849, 205535, 261287, 310384, 310385, 313989

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce7d40ce-bfb8-ee15-a060-423ec90d7ac9Product name620250331
e5b459e3-ddce-4802-aab4-2c901d71ae85Product name520250129
6d3d5b3a-d6b8-8417-8428-6414b08f1464Product name320240130
e7177a8f-11de-ee90-ca22-068e6ef54cf5Product name420230104
82da1192-6e97-fa73-2f85-6a50c10b4704Product name320161212
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0777-3104-02Prozac100 in 1 BOTTLECAPSULE10059

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0777-3104-02EA - Each0777-3104b55499ab-83fe-4b9f-ba6a-87e01ffb919112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fluoxetine hydrochlorideACTIVE INGREDIENTI9W7N6B1KJPROZAC (FLUOXETINE HYDROCHLORIDE) CAPSULE [DISTA PRODUCTS COMPANY]39
FluoxetineACTIVE MOIETY01K63SUP8DPROZAC (FLUOXETINE HYDROCHLORIDE) CAPSULE [DISTA PRODUCTS COMPANY]39
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OPROZAC (FLUOXETINE HYDROCHLORIDE) CAPSULE [DISTA PRODUCTS COMPANY]39
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDPROZAC (FLUOXETINE HYDROCHLORIDE) CAPSULE [DISTA PRODUCTS COMPANY]39
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PROZAC (FLUOXETINE HYDROCHLORIDE) CAPSULE [DISTA PRODUCTS COMPANY]39
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPROZAC (FLUOXETINE HYDROCHLORIDE) CAPSULE [DISTA PRODUCTS COMPANY]39
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PROZAC (FLUOXETINE HYDROCHLORIDE) CAPSULE [DISTA PRODUCTS COMPANY]39
GelatinINACTIVE INGREDIENT2G86QN327LPROZAC (FLUOXETINE HYDROCHLORIDE) CAPSULE [DISTA PRODUCTS COMPANY]39
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JPROZAC (FLUOXETINE HYDROCHLORIDE) CAPSULE [DISTA PRODUCTS COMPANY]39
STARCH, CornINACTIVE INGREDIENTO8232NY3SJPROZAC (FLUOXETINE HYDROCHLORIDE) CAPSULE [DISTA PRODUCTS COMPANY]39
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPROZAC (FLUOXETINE HYDROCHLORIDE) CAPSULE [DISTA PRODUCTS COMPANY]39

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0777-3104PROZAC (FLUOXETINE HYDROCHLORIDE) CAPSULE [DISTA PRODUCTS COMPANY]58Current NDC, Legacy NDC, 1 package rows20241211_c88f33ed-6dfb-4c5e-bc01-d8e36dd97299.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSNc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
310385FLUoxetine 20 MG Oral CapsulePSNc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
313989FLUoxetine 40 MG Oral CapsulePSNc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
205535PROzac 10 MG Oral CapsulePSNc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
104849PROzac 20 MG Oral CapsulePSNc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
261287PROzac 40 MG Oral CapsulePSNc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
205535fluoxetine 10 MG Oral Capsule [Prozac]SBDc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
104849fluoxetine 20 MG Oral Capsule [Prozac]SBDc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
261287fluoxetine 40 MG Oral Capsule [Prozac]SBDc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
310384fluoxetine 10 MG Oral CapsuleSCDc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
310385fluoxetine 20 MG Oral CapsuleSCDc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
313989fluoxetine 40 MG Oral CapsuleSCDc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSYc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
205535Prozac 10 MG (fluoxetine hydrochloride 11.2 MG) Oral CapsuleSYc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
205535Prozac 10 MG Oral CapsuleSYc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
104849Prozac 20 MG (fluoxetine HCl 22.4 MG) Oral CapsuleSYc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
104849Prozac 20 MG Oral CapsuleSYc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
261287Prozac 40 MG (fluoxetine hydrochloride 44.8 MG) Oral CapsuleSYc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959
261287Prozac 40 MG Oral CapsuleSYc88f33ed-6dfb-4c5e-bc01-d8e36dd9729959

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0777-3104-0200777310402100 CAPSULE in 1 BOTTLE (0777-3104-02) 100 capsule1993-01-132026-12-06NoNoCurrent